40 results · 21ms · Sources: EU EUDAMED, US FDA

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SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Affiniti

FDA UDI
TORNIER, INC.·00846832024803·GLENOID REAMER

TEWA

FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282502744·TeWa CJ-Type 3025: coated acupuncture needles ...

TEWA

FDA UDI
asia-med GmbH·04251282510060·TeWa CJ-Type 3025: coated acupuncture needles ...

Isolator Surgical Ablation System

FDA UDI
ATRICURE, INC.·00818354010756·Isolator Synergy Surgical Ablation System, Glid...

PowerPICC SOLO

FDA UDI
Bard Access Systems, Inc.·00801741104190·Catheter Placement Kit

Isolator Surgical Ablation System

FDA UDI
ATRICURE, INC.·10840143902161·Isolator Synergy Surgical Ablation System, Glid...

Zavation

FDA UDI
Zavation LLC·00842166167599·4-Level, 52mm Cervical Plate

PenEvac1

FDA UDI
I.C. MEDICAL, INC.·00817688020004·

BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

TUFF PRO IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·February 23, 2025

TUFF PRO IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·September 25, 2024

TUFF PRO IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·February 23, 2025

X-RAY MONOBLOCK, MONOBLOCK XRS-60-330

FDA 510(k)
FDA Class 1 ·Radiology

KIPPMED I.V. MANIFOLD

FDA 510(k)
FDA Class 2 ·General Hospital

First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash# Size: Honeywell Part# K206125 LXXV - 75V " Economy Cabinet 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K 206154 LXXV - 75V " Deluxe Cabinet 3 Shelf RS08016 Eye Wash - 4 oz. 32-000452-0000 K206210 FAC- 3 Deluxe Cabinet 3 Shelf R508016 Eye Wash - 4 oz. 32-000452-0000 K606999 ZLBCSX CPR Kit 37 R508016 Eye Wash " 4 oz. 32-000452-0000 KR206152 FAC " 4R 200 Person Deluxe Cabinet - Refill R508016 Eye Wash 4 oz. 32-000452-0000 K608054 Cement Burn Cabinet R511018 Eye Wash " 16 oz. 32-000454 0000- H5 K610045 FAC.3 " Deluxe Cabinet .w/BBP .NO MEDS .3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K606289 Eye Wash Cabinet 316 R511018 Eye Wash - 16oz 32-000454-0000-HS K608061 36MDelmarva Power/ACEw/Logo R508016 Eye Wash4 oz. 32-000452-0000 K611017 16PW " Hospeco " w/logo R508016 Eye Wash " 4 oz. 32-000452-0000 K206152 FAC4 200 Person Deluxe Cabinet 4 Shelf R508016 Eye Wash4 oz. 32-000452-0000 K206140 CLX 100 Person Deluxe Cabinet " 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 KR206210 FAC " 3R " Deluxe Cabinet Refill R508016 Eye Wash " 4 oz 32-000452-0000 K209061 TRMK Trauma Kit with Orange Co-Polymer Case R511018 Eye Wash -16 oz. 32-000454-0000-HS K206130 LXXV7SHStandard Cabinet Swing Out Door2 Shelf R508016 Eye Wash " 4 oz 32-000452-0000 Product Usage: various first aid/emergency kits containing eyewash

FDA Recall
Terminated ·Certified Safety Mfg Inc·Product code LRR·March 20, 2018

First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash# Size: Honeywell Part# K206125 LXXV - 75V " Economy Cabinet 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K 206154 LXXV - 75V " Deluxe Cabinet ¿3 Shelf RS08016 Eye Wash - 4 oz. 32-000452-0000 K206210 FAC- 3 ¿Deluxe Cabinet ¿3 Shelf R508016 Eye Wash - 4 oz. 32-000452-0000 K606999 ZLB¿CSX CPR Kit 37 R508016 Eye Wash " 4 oz. 32-000452-0000 KR206152 FAC " 4R ¿200 Person Deluxe Cabinet - Refill R508016 Eye Wash ¿4 oz. 32-000452-0000 K608054 Cement Burn Cabinet R511018 Eye Wash " 16 oz. 32-000454 0000- H5 K610045 FAC.3 " Deluxe Cabinet .w/BBP .NO MEDS .3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K606289 Eye Wash Cabinet ¿316 R511018 Eye Wash - 16oz 32-000454-0000-HS K608061 36M¿Delmarva Power/ACE¿w/Logo R508016 Eye Wash¿4 oz. 32-000452-0000 K611017 16PW " Hospeco " w/logo R508016 Eye Wash " 4 oz. 32-000452-0000 K206152 FAC¿4 ¿200 Person Deluxe Cabinet ¿4 Shelf R508016 Eye Wash¿4 oz. 32-000452-0000 K206140 CLX ¿100 Person ¿Deluxe Cabinet " 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 KR206210 FAC " 3R " Deluxe Cabinet ¿Refill R508016 Eye Wash " 4 oz 32-000452-0000 K209061 TRMK ¿Trauma Kit with Orange Co-Polymer Case R511018 Eye Wash -16 oz. 32-000454-0000-HS K206130 LXXV¿7SH¿Standard Cabinet Swing Out Door¿2 Shelf R508016 Eye Wash " 4 oz 32-000452-0000 Product Usage: various first aid/emergency kits containing eyewash

FDA Enforcement
Class II ·Terminated·Certified Safety Mfg Inc·April 18, 2018

ATRICURE BIPOLAR SYSTEM

FDA Adverse Event
Death ·ATRICURE, INC.·Product code GEI·March 3, 2010

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 12, 2013

TALENT ABDOMINAL STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·February 18, 2011